US-MA, Medical Director Global Patient Safety - Oncology 1800311-MZ

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Director, Global Patient Safety - Oncology in ourCambridgeoffice.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Medical Director working on the Global Patient Safety team in Oncology, you will be empowered to Innovate, Collaborate and set Strategy. A typical day will include:

OBJECTIVES:

Support developmental programs, including both early and late stage development as required.

Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate.

Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs

Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL Company wide safety expert for his/her compound responsibilities

Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for own compounds with input for other compounds as needed.

Serving in a leadership capacity for complex and strategically important programs

Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive

Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc

Training and mentoring of Pharmacovigilance Physicians and Specialists

Perform activities required to serve as Global PV physician:

Review and oversight of safety data, both non-clinical and clinical

Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities

Interactions with external experts and regulatory agencies and partner/co-development companies

Review of safety data and participate in dose escalation decisions

Authorship and sign off of Safety Monitoring Plan/Risk Management Plan

Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators

Direct the set up of safety procedures and development of safety exchange agreements for co-development projects

Maintain professional knowledge and accreditation by active participation in continuing medical education activities

ACCOUNTABILITIES:

Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL.

Company wide safety expert for his/her compound responsibilities

Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for own compounds with input for other compounds as needed.

Serving in a leadership capacity for complex and strategically important programs

Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc

Training and mentoring of Pharmacovigilance Physicians and Specialists

Perform activities required to serve as Global PV physician:

Review and oversight of safety data, both non-clinical and clinical

Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities

Interactions with external experts and regulatory agencies and partner/co-development companies

Review of safety data and participate in dose escalation decisions

Maintain professional knowledge and accreditation by active participation in continuing medical education activities

Authorship and sign off of Safety Monitoring Plan/Risk Management Plan

Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators

Direct the set up of safety procedures and development of safety exchange agreements for co-development projects

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Qualified physician (License, e.g. GMC registered, preferred)

Knowledge of principles of epidemiology and statistics.

Critical thinking and analytical skills and ability to make high level decisions

Excellent oral and written communication skills including ability to present to large internal/external groups

* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.